The Official CORMEDIX (CRMD)thread (run up to FDA approval has begun )
- Thread starter Tug life
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Amarin Provides Update to Preliminary 2019 Results and Further Details on 2020 Outlook
Yahoo is now part of Verizon Media
Yahoo is now part of Verizon Media
Nice.
Lots of chatter about this on the boards this morning. Gonna read as much as I can b4 I tap.
Still not sure why guidance is that low, with sale force doubling amd TAM just increased multiple times with Expanded Label.
I get under promise and over deliver, but at least give us some guidance we can get excited about.
Yesterday Mochida (AMRN's Drug Developer) started P3 of Vascepa 2.0. 1 daily, self emulsifying, EPA product, Greater Bioavailability, and no fatty meal recommendation.
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia - Tabular View - ClinicalTrials.gov
old thread, but good info here:
Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia - Tabular View - ClinicalTrials.gov
old thread, but good info here:
Tug life
I stay fly like a guillemot
I can't confirm if this is true or not but this post below is said to be from the CEO of Acasti Jan D'Alvise to a large investor sent this morning saying a announcement and PR is coming tomorrow at 6 a.m. again I can't confirm if it's real or not but there has been some reliable news leaks on Acasti in the last month
Tug life
I stay fly like a guillemot
Acasti failed the study, down 50% in the pre market right now and I'm sick to my stomach. This one is gonna hurt for a while. I know a good amount of us had money here. Damn this sucks
Tug life
I stay fly like a guillemot
The trail failed because the placebo the used cornstarch, decreased trigs by a good amount which is odd to say the least. It's still another phase 3 trail coming next month, I might just have to hold and see how it plays out
"While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic OM3 hypertriglyceridemia trials. Several hypotheses are being investigated now by our clinical team, and by our CRO and Dr. Mozaffarian. These avenues of investigation are being carefully and rigorously pursued, and we are moving as quickly as possible to try to gain understanding and insight into the large and unexpected placebo response seen in TRILOGY 1. The Company will continue to provide updates on this investigation, as well as topline results for TRILOGY 2 as we get them, to be followed by all secondary and exploratory endpoints for TRILOGY 1 and 2 once the TRILOGY 2 study is completed and fully analyzed.”
"While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic OM3 hypertriglyceridemia trials. Several hypotheses are being investigated now by our clinical team, and by our CRO and Dr. Mozaffarian. These avenues of investigation are being carefully and rigorously pursued, and we are moving as quickly as possible to try to gain understanding and insight into the large and unexpected placebo response seen in TRILOGY 1. The Company will continue to provide updates on this investigation, as well as topline results for TRILOGY 2 as we get them, to be followed by all secondary and exploratory endpoints for TRILOGY 1 and 2 once the TRILOGY 2 study is completed and fully analyzed.”
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damn breh. sorry to hear that. hopefully it rebounds. crazy that corn starch had that effect.
on a side note, i wonder what this does for amarin's stock
EDIT
just saw amarin is up a dollar pre-market. so hopefully that helps to offset some of your losses
AMRN is moving in light volume this morning.
It was up 12% earlier. Here's more news:
Yahoo is now part of Verizon Media
It was up 12% earlier. Here's more news:
Yahoo is now part of Verizon Media
Tug life
I stay fly like a guillemot
After calming down and reading further into it, I decided to average down. They hit every mark above 30% which is really good and Had it not been for that unusual placebo effect it would have been seen as successful.
The placebo which is cornstarch showed to lower triglyceride levels at 28% which is like a drug itself and that doesn't make any sense. I'll hold until they figure this out, their is an audit underway should know in February. And they also have another trail they are reporting next month so if that placebo effect was just an anomaly than TRILOGY 2 should be a successful trail.
Acasti Pharma Reports Topline Results for TRILOGY 1 Phase 3 Trial of CaPre
Reports 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among patients receiving CaPre at 12 and 26 weeks respectively, as well as 42.2% reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks
Despite positive results in CaPre arm, study did not reach statistical significance
due to unusually large placebo effect; further analysis is underway
No treatment-related serious adverse events reported in the trial
The last patient completed their final visit in the TRILOGY 2 trial late last week,
topline results expected now by mid-February 2020
The placebo which is cornstarch showed to lower triglyceride levels at 28% which is like a drug itself and that doesn't make any sense. I'll hold until they figure this out, their is an audit underway should know in February. And they also have another trail they are reporting next month so if that placebo effect was just an anomaly than TRILOGY 2 should be a successful trail.
Acasti Pharma Reports Topline Results for TRILOGY 1 Phase 3 Trial of CaPre
Reports 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among patients receiving CaPre at 12 and 26 weeks respectively, as well as 42.2% reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks
Despite positive results in CaPre arm, study did not reach statistical significance
due to unusually large placebo effect; further analysis is underway
No treatment-related serious adverse events reported in the trial
The last patient completed their final visit in the TRILOGY 2 trial late last week,
topline results expected now by mid-February 2020
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Tug life
I stay fly like a guillemot
Thanks bro im good now, I've looked into it deeper and a 28% cornstarch effect has to be some type of error. And besides that one thing, Capre lowers trigs more that Amarins drug vescepa so I'm just going to average down. I believe this will all get sorted out
In regards to AMRN’s patent case
Key Takeaway
We are attending the AMRN court case in Reno, NV. Day 1 included opening statements and direct/cross-examination of AMRN's CSO. Our initial takeaway is Hikma/Reddy's appeared to be aggressive as expected. While it is just the first day and still early, we will be interested in seeing how AMRN responds and any commentary from the Judge. The trial is scheduled for 3 weeks w/ pot'l decision by March/April.
Insights
Summary: Today began with each side giving 20-25 min opening statements w/ 15-25 exhibits (e.g., KOL statements, excerpts from publications, etc). We found the opening arguments mostly in line, with each side outlining claims in favor or against the non-obviousness of the (+) effects of Vascepa and infringement of the approved label. Direct examination of AMRN's CSO Dr. Ketchum was most interesting in providing insight into the development of Vascepa. Cross-examination was focused on demonstrating the obviousness of the Vascepa results through several examples of AMRN using/discussing prior studies (e.g., JELIS study) to support continued development of Vascepa. While early, Hikma/Reddy's were aggressive in their line of questioning. Overall however, we maintain a positive view on AMRN and believe AMRN will see their patent upheld and they are in a good position to win.
Opening arguments...Hikma/Reddy's appeared particularly cogent. AMRN attorneys claimed: 1)VASCEPA results were non-obvious, particularly the decrease in Trigs w/o an increase in LDL, citing review articles and other statements at the time suggesting it was universally believed prior to Vascepa an LDL increase w/ trig reduction was an unavoidable on target effect. 2) While the label does not specify a duration of treatment with Vascepa, it is implied EPA has to be given chronically as the disease is mostly genetic and even the FDA's review documents for Vascepa refer to the drug for chronic administration.
The defense (Hikma/Reddy) opening arguments claimed: 1) based on the literature, it was obvious that DHA increased LDL, and removal of this component could potentially reduce Trigs w/o impacting LDL. The defense also claimed the patent examiner cited this prior art. 2) Nothing in the label states/requires chronic therapy and they made the argument that it as reasonable to give EPA for <12 wks followed by proper exercise and diet to manage trigs. As a reminder, in our diligence with experts, a significant majority of doctors would need to believe this and the burden is on the defense to prove this.
During cross-examination the defense cited several examples of AMRN using publications to support the development of Vascepa. The defense claimed March 2008 was the critical date AMRN is said to have created Vascepa. To support its view AMRN's patents were invalid due to obviousness, the defense went through several documents, including internal emails, regulatory documents (e.g., pre-IND,sNDA, etc) to FDA and presentations to investors citing clinical studies done before 2008 supporting the use of an EPA only product. In response, the plaintiff made the argument that while citing these studies, they were flawed or had caveats that made drawing overarching conclusion not obvious.
Key Takeaway
We are attending the AMRN court case in Reno, NV. Day 1 included opening statements and direct/cross-examination of AMRN's CSO. Our initial takeaway is Hikma/Reddy's appeared to be aggressive as expected. While it is just the first day and still early, we will be interested in seeing how AMRN responds and any commentary from the Judge. The trial is scheduled for 3 weeks w/ pot'l decision by March/April.
Insights
Summary: Today began with each side giving 20-25 min opening statements w/ 15-25 exhibits (e.g., KOL statements, excerpts from publications, etc). We found the opening arguments mostly in line, with each side outlining claims in favor or against the non-obviousness of the (+) effects of Vascepa and infringement of the approved label. Direct examination of AMRN's CSO Dr. Ketchum was most interesting in providing insight into the development of Vascepa. Cross-examination was focused on demonstrating the obviousness of the Vascepa results through several examples of AMRN using/discussing prior studies (e.g., JELIS study) to support continued development of Vascepa. While early, Hikma/Reddy's were aggressive in their line of questioning. Overall however, we maintain a positive view on AMRN and believe AMRN will see their patent upheld and they are in a good position to win.
Opening arguments...Hikma/Reddy's appeared particularly cogent. AMRN attorneys claimed: 1)VASCEPA results were non-obvious, particularly the decrease in Trigs w/o an increase in LDL, citing review articles and other statements at the time suggesting it was universally believed prior to Vascepa an LDL increase w/ trig reduction was an unavoidable on target effect. 2) While the label does not specify a duration of treatment with Vascepa, it is implied EPA has to be given chronically as the disease is mostly genetic and even the FDA's review documents for Vascepa refer to the drug for chronic administration.
The defense (Hikma/Reddy) opening arguments claimed: 1) based on the literature, it was obvious that DHA increased LDL, and removal of this component could potentially reduce Trigs w/o impacting LDL. The defense also claimed the patent examiner cited this prior art. 2) Nothing in the label states/requires chronic therapy and they made the argument that it as reasonable to give EPA for <12 wks followed by proper exercise and diet to manage trigs. As a reminder, in our diligence with experts, a significant majority of doctors would need to believe this and the burden is on the defense to prove this.
During cross-examination the defense cited several examples of AMRN using publications to support the development of Vascepa. The defense claimed March 2008 was the critical date AMRN is said to have created Vascepa. To support its view AMRN's patents were invalid due to obviousness, the defense went through several documents, including internal emails, regulatory documents (e.g., pre-IND,sNDA, etc) to FDA and presentations to investors citing clinical studies done before 2008 supporting the use of an EPA only product. In response, the plaintiff made the argument that while citing these studies, they were flawed or had caveats that made drawing overarching conclusion not obvious.
NexTech AR Solutions (NexTech) (NEXCF) (CSE:NTAR) (N29.F), the leader in augmented reality (AR) for eCommerce and AR learning applications is pleased to announce that NexTech CEO Evan Gappelberg will be presenting at Wall Street Reporter’s “Next Super Stock” livestream conference on January 15, 2020.
' data-reactid="11">NEW YORK and TORONTO, Jan. 14, 2020 (GLOBE NEWSWIRE) -- NexTech AR Solutions (NexTech) (NEXCF) (CSE:NTAR) (N29.F), the leader in augmented reality (AR) for eCommerce and AR learning applications is pleased to announce that NexTech CEO Evan Gappelberg will be presenting at Wall Street Reporter’s “Next Super Stock” livestream conference on January 15, 2020.
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Evan will update investors on NexTech’s latest advances, and record revenue growth, as the company pursues four multi-billion dollar verticals in AR, including the 3D/AR ad network which is about to be launched by the company.
Yahoo is now part of Verizon Media
PRed another deal today with a Mining Co. Been doing more DD. Profit margins are expected to reach between 60-70% nx year.
More on the Mining Co...
Before NexTech, the core samples were judged using 2D photographs. Now with nexTech, this company will be able to send a 8K 3D image to possible buyers that will allow them to rotate, zoom in etc...
CEO said, the Mining industry wasn't even on their radar. Now, they'll be attending a Mining Conf. up in Canada to pitch their Tech later this week.
' data-reactid="11">NEW YORK and TORONTO, Jan. 14, 2020 (GLOBE NEWSWIRE) -- NexTech AR Solutions (NexTech) (NEXCF) (CSE:NTAR) (N29.F), the leader in augmented reality (AR) for eCommerce and AR learning applications is pleased to announce that NexTech CEO Evan Gappelberg will be presenting at Wall Street Reporter’s “Next Super Stock” livestream conference on January 15, 2020.
CLICK HERE TO SIGN UP' data-reactid="12">CLICK HERE TO SIGN UP
Evan will update investors on NexTech’s latest advances, and record revenue growth, as the company pursues four multi-billion dollar verticals in AR, including the 3D/AR ad network which is about to be launched by the company.
Yahoo is now part of Verizon Media
PRed another deal today with a Mining Co. Been doing more DD. Profit margins are expected to reach between 60-70% nx year.
More on the Mining Co...
Before NexTech, the core samples were judged using 2D photographs. Now with nexTech, this company will be able to send a 8K 3D image to possible buyers that will allow them to rotate, zoom in etc...
CEO said, the Mining industry wasn't even on their radar. Now, they'll be attending a Mining Conf. up in Canada to pitch their Tech later this week.